Data / Medical devices / France / Tissium SA
Tissium SA: FDA-registered device maker in Paris 20e Arrondissement, France, 1 510(k) clearance
Tissium SA is registered with the FDA (registration 3021453307) in Paris 20e Arrondissement, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 17, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021453307
- Address
- 18 Avenue Leon Gaumont, Paris 20e Arrondissement, France, 75020
- Owner or operator
- TISSIUM (10093777)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 9, 2025
- Registered through
- 2026
- Brand names listed
- COAPTIUM Connect, COAPTIUM Selector, TISSIUM LIGHT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| In Situ Polymerizing Peripheral Nerve Repair Device | SFD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 17, 2025 | DEN240066 | COAPTIUM Connect with TISSIUM LIGHT | SFD | Unknown | Tissium SA | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 15, 2026 | 99345 | Class II | Ongoing | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery. | accessdata.fda.gov |
Compare with other makers
- All makers of In Situ Polymerizing Peripheral Nerve Repair Device
- All makers of Instrument, Surgical, Non-Powered
Updated August 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.